Ascend recalls atorvastatin tablets for dissolution failures

Ascend Laboratories has recalled 141,984 bottles of atorvastatin calcium tablets distributed nationwide after laboratory testing found the pills failed dissolution specifications, federal officials said. The recall, announced in September and classified by the U.S. Food and Drug Administration as a Class II action in October, covers 10 mg, 20 mg, 40 mg and 80 mg tablets packaged in 90‑count, 500‑count and 1,000‑count bottles that were manufactured by Alkem Laboratories in India and distributed in the United States by Ascend Laboratories, a New Jersey company.

Failed dissolution specifications indicate that a tablet did not dissolve in testing the way it is expected to, which can affect the rate and extent to which the active ingredient is released for absorption. That could make the medicine less effective at lowering cholesterol or, depending on the deviation, alter the amount of drug a patient receives. The FDA described a Class II recall as when use "may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

Federal records list eight lot numbers included in the recall, with expiration...